MODEL DT-BAL, BALANCE SAVER
FDA 510(k) clearance K895323 · decided 1989-10-24
Clearance details
- K-number
- K895323
- Device name
- MODEL DT-BAL, BALANCE SAVER
- Applicant
- Spectramed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-08-29
- Decision date
- 1989-10-24
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- KXO
- Device class
- 2
- Regulation number
- 884.2700
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Oxnard, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.